Viewing Study NCT00425945



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Last Modification Date: 2024-10-26 @ 9:30 AM
Study NCT ID: NCT00425945
Status: COMPLETED
Last Update Posted: 2014-04-02
First Post: 2007-01-23

Brief Title: Understanding Pine Bark Extract as an Alternative Treatment UPBEAT Study
Sponsor: Stanford University
Organization: Stanford University

Study Overview

Official Title: Cardiovascular Effects of Pine Bark Extract
Status: COMPLETED
Status Verified Date: 2014-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study is to investigate the efficacy of Flavangenol Toyo Shinyaku Japan a pine bark extract in lowering blood pressure and improving glycemic control and plasma lipoprotein profile
Detailed Description: Cardiovascular disease is the number one cause of death in the Unites States Our study tests the efficacy of pine bark extract in improving a number of cardiovascular disease risk factors We are conducting a randomized placebo-controlled double-blind parallel trial that will investigate the efficacy and safety of Flavangenol Toyo Shinyaku Japan a pine bark extract among 130 study participants These participants will be individuals at mildly or moderately elevated risk of cardiovascular disease CVD because of having prehypertension excess body weight and insulin insensitivity We aim to determine in order of priority

1 The efficacy of Flavangenol in lowering blood pressure
2 The efficacy of Flavangenol in improving glycemic control and plasma lipoprotein profile
3 Changes in body weight antioxidative capacity anti-inflammatory markers blood coagulation factors and liver function tests in response to Flavangenol
4 The safety of Flavangenol as confirmation of past studies

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None